Valsartan SPC – German PI Proceedings

In Germany, Novartis obtained an ex parte preliminary injunction from the Regional Court Düsseldorf against a generic company on the basis of SPC DE 196 75 036. The injunction was awarded on 17 December 2010. Then on 8 March 2011, after the defendant filed an objection against the preliminary injunction, the Regional Court Düsseldorf confirmed its decision in view of an imminent threat of infringement of the SPC.

DE 196 75 036 is directed to the product valsartan. The generic product at issue was a combination product containing valsartan and hydrochlorothiazide. The generic company had put the claimant on notice of its intention to distribute the combination products before expiration of the SPC in Germany.

The court found that infringement of the SPC regarding valsartan was imminent. It rejected the defendant’s submission that Art. 4 of Regulation 469/2009 (the ‘SPC Regulation’) would limit the protective scope of the SPC to the product covered by the marketing authorisation of the corresponding medicinal product, i.e. to the mono product valsartan.

The court emphasized that the purpose of the limitation of the protection to “the product covered by the authorisation to place the corresponding medicinal product on the market” provided by Art. 4 SPC Regulation would be decisive for determining the scope of the protection afforded by an SPC.

Art. 4 would stipulate three criteria in this regard:

the absolute limit of protection defined by the scope of protection of the basic patent (in a declaratory manner);

the identification of the product in order to delimit it from other compounds falling under the scope of protection of the basic patent; and

The court concluded that Art. 4 SPC Regulation could not be replaced by a mere rule extending the whole technical teaching subject to the claims of the patent, and would thus not be redundant in view of the third criterion. The extended patent should, rather fictitiously, be considered as if it would be limited to the active ingredient identified in the SPC. This would result in a hypothetical patent claim related to product and purpose.

The court concluded that, pursuant to the general principles of patent law applicable to SPCs under Art. 4 and 5 of the SPC Regulation, it is irrelevant when considering infringement whether a medicinal product shows additional features other than the claimed active ingredient. In particular, in the case at issue, infringement could not be excluded if a medicinal product contained one of more other active ingredients in addition to valsartan.

According to this decision, any pharmaceutical (combination) product containing the active ingredient subject to an SPC would have to be considered to be infringing, regardless of which additional substances it contains, or whether a different marketing authorisation is required than for the (mono) product identified in the SPC.